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A Phase 3, Randomized, Open-Label Study of Lopinavir/Ritonavir Tablets 800/200 mg Once-Daily Versus 400/100 mg Twice-Daily When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-Experienced, HIV-1 Infected Subjects.

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Trial Profile

A Phase 3, Randomized, Open-Label Study of Lopinavir/Ritonavir Tablets 800/200 mg Once-Daily Versus 400/100 mg Twice-Daily When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-Experienced, HIV-1 Infected Subjects.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Lopinavir/ritonavir (Primary) ; Nucleoside reverse transcriptase inhibitors; Nucleotide reverse transcriptase inhibitors
  • Indications HIV-1 infections
  • Focus Pharmacodynamics; Registrational; Therapeutic Use
  • Sponsors Abbott Laboratories
  • Most Recent Events

    • 29 Apr 2010 The FDA has approved once-daily dosing of lopinavir/ritonavir for treatment-experienced HIV-1 infected adults, on the basis of these trial results.
    • 19 Feb 2010 An analysis of HIV protease inhibitor resistance and adherence has been reported at the 17th Conference on Retroviruses and Opportunistic Infections (CROI 2010).
    • 09 Feb 2010 Actual initiation date changed from Sep 2006 to Aug 2006 as reported by ClinicalTrials.gov.

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